A clinical study to see the effect of some Ayurvedic formulation in the management of arthritis.

Phase 2

• Conditions: Health Condition 1: null- Osteoarthritis

• Registration Number: CTRI/2012/02/002416
• Lead Sponsor: Department of AYUSH Ministry of Health and Family Welfare Government of India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex aged between 40 and 75 years.

2. Patients with Primary Osteoarthritis (Diagnosis to be confirmed by Kellgren Lawrence Radiological scale)

3. Pain in the affected joint(s) > six weeks.

4. Willing and able to participate in the study.

Exclusion Criteria

1. History of any surgical /diagnostic intervention with reference to the affected joint(s).

2. Patients who are incapacitated, bedridden or confined to a wheelchair.

3. Patients with co morbidities such as gouty arthritis, rheumatoid arthritis and psoriatic arthritis

4. Patients having any deformity of knee, hip or back.

5. Patients with poorly controlled Hypertension ( >160/100 mm of Hg)

6. Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg% or HbA1c > 6.5%}.

7. Patients with evidence of malignancy.

8. Patients on prolonged ( > 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

9. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,

Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

10. Symptomatic patients with clinical evidence of Heart failure.

11. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino

Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.

12. Alcoholics and/or drug abusers.

13. H/o hypersensitivity to any of the trial drugs or their ingredients.

14. Pregnant / lactating woman.

15. Patients who have completed participation in any other clinical trial during the past

six (06) months.

16. Any other condition which the Principal Investigator thinks may jeopardize the

study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified